Viatris Provides Pipeline Update on Four Regulatory Milestones

Rhea-AI Summary

Viatris (Nasdaq: VTRS) reported four regulatory milestones across its global pipeline on Dec 18, 2025: FDA approval of a generic octreotide acetate injectable suspension (generic Sandostatin LAR Depot); FDA acceptance of an NDA for a low dose estrogen weekly contraceptive patch with a PDUFA date of July 30, 2026; FDA clearance of an IND for MR-146 AAV gene therapy with a planned Phase 1/2 CORVITA trial in H1 2026; and PMDA acceptance of a J-NDA for pitolisant in obstructive sleep apnea syndrome, with a J-NDA for narcolepsy still on track by year-end.

These items advance development and regulatory pathways across generics, women’s health, ophthalmology gene therapy, and sleep-disorder franchises.

Positive

• FDA approval of generic octreotide acetate for Sandostatin LAR Depot
• NDA accepted with PDUFA date: July 30, 2026 for weekly estrogen contraceptive patch
• IND cleared for MR-146 with Phase 1/2 trial planned in H1 2026
• PMDA acceptance of J-NDA for pitolisant in obstructive sleep apnea syndrome

Negative

• Commercial outcomes pending — approvals and trial results remain unresolved
• Regulatory timing risk tied to the July 30, 2026 PDUFA action date

Key Figures

Norelgestromin dose 150 mcg Low dose estrogen weekly patch for contraception

Ethinyl estradiol dose 17.5 mcg Low dose estrogen weekly patch for contraception

PDUFA date July 30, 2026 FDA target action date for low dose estrogen weekly patch NDA

Trial phase Phase 1 / 2 Planned CORVITA clinical trial for MR-146 in NK

IND cleared MR-146 FDA cleared Investigational New Drug application for neurotrophic keratopathy

FDA approval Generic Sandostatin LAR Octreotide acetate for injectable suspension approved in the U.S.

J-NDA accepted Pitolisant OSAS PMDA acceptance for obstructive sleep apnea syndrome in Japan

J-NDA timeline End of 2025 Company target to submit J-NDA for narcolepsy

Market Reality Check

$11.93 Last Close

Volume Volume 7624842 is close to the 20-day average of 7541524, suggesting typical activity before this update. normal

Technical Price 11.7 is trading above the 200-day moving average at 9.51, indicating a pre-existing upward trend.

Peers on Argus

Peers showed mixed moves: NBIX -5.83%, ELAN -2.08%, TEVA -0.18%, while UTHR +2.16% and RDY 0%. This pattern does not indicate a unified sector move alongside VTRS.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 24	Investor conferences	Neutral	+1.1%	Participation in two early December healthcare investor conferences.
Nov 13	Workplace recognition	Positive	-0.9%	Named among Fortune World’s Best Workplaces 2025 list of 25 firms.
Nov 06	Earnings and guidance	Negative	-6.0%	Q3 2025 results with lower EBITDA/EPS and updated 2025 guidance.
Nov 04	Dividend declaration	Positive	-0.4%	Board declared a <b>$0.12</b> per share quarterly dividend payable in December.
Oct 28	R&D collaboration	Positive	-1.3%	Collaboration with Locus Biosciences on bacteriophage therapies for eye infections.

Pattern Detected

Recent history shows several positive or neutral headlines followed by flat-to-negative price reactions, especially around earnings, dividends, and collaborations.

Recent Company History

Over the last few months, Viatris reported Q3 2025 results with $3.76B revenue and updated guidance, maintained a $0.12 quarterly dividend, and announced an ophthalmic collaboration with Locus Biosciences. It also received workplace recognition and attended major healthcare investor conferences in early December 2025. Against this backdrop, today’s multi-asset regulatory update (U.S. approval, NDA/IND progress, and a Japanese J-NDA) expands the pipeline beyond earlier financial and governance-focused disclosures.

Market Pulse Summary

This announcement highlights four regulatory milestones spanning generics, women’s health, gene therapy, and sleep disorders, including U.S. approval of a generic Sandostatin LAR, NDA and IND progress, and a Japanese J-NDA acceptance. These build on earlier 2025 developments such as Q3 revenues of $3.76B, updated guidance, and R&D collaborations. Investors may watch upcoming catalysts like the July 30, 2026 PDUFA date, initiation of the Phase 1/2 MR-146 trial, and further Japanese filings to gauge execution on this pipeline.

Key Terms

new drug application regulatory

"U.S. FDA Accepts New Drug Application for Low Dose Estrogen Weekly Patch"

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

505(b)(2) regulatory

"The NDA is accepted under the FDA's 505(b)(2) regulatory pathway"

A 505(b)(2) is an FDA drug approval pathway that lets a company win approval by relying partly on existing studies or published data instead of doing all new clinical trials. Think of it like building a renovated house using the original foundation: it can be faster and less costly than a full new-drug route, reducing development risk and expense. Investors care because it can speed market entry, lower capital needs, and offer opportunities for exclusivity or competitive advantage.

pdufa regulatory

"the FDA has assigned a target action date (PDUFA) of July 30, 2026"

PDUFA, short for the Prescription Drug User Fee Act, is a law that allows drug companies to pay fees to the government to speed up the review process for new medicines. This helps bring important drugs to market more quickly, which can impact their availability and pricing. For investors, PDUFA timelines can influence the timing of a drug’s approval and potential market success.

investigational new drug regulatory

"U.S. FDA Clears Investigational New Drug Application for MR-146"

An investigational new drug is a medication that is still being tested in clinical trials to determine if it is safe and effective for treating a specific condition. For investors, it represents a potential breakthrough that could lead to a new treatment and significant financial gains if successful, but also carries risks since it has not yet been approved for widespread use.

gene therapy medical

"AAV gene therapy candidate targeted to treat people with neurotrophic keratopathy"

Gene therapy is a medical technique that involves altering or replacing faulty genes in a person's cells to treat or prevent disease. It is considered a promising area of innovation because it has the potential to provide long-term or even permanent solutions to genetic conditions. For investors, advancements in gene therapy can signal opportunities in biotech companies and emerging treatments with significant growth potential.

adeno-associated virus medical

"Enriched Tear FilmTM (ETF) Adeno-Associated Virus (AAV) gene therapy candidate"

Adeno-associated virus (AAV) is a naturally occurring, small virus that researchers use as a safe carrier to deliver corrective genes into human cells, much like a specialized delivery van transporting instructions to a malfunctioning machine. It matters to investors because AAV-based therapies drive large development costs, unique manufacturing and regulatory risks, and the potential for high-value, one-time treatments that can significantly affect a biotech company’s future revenue and valuation.

neurotrophic keratopathy medical

"gene therapy candidate targeted to treat people with neurotrophic keratopathy (NK)"

Neurotrophic keratopathy is a rare eye condition in which damage to the cornea’s nerve supply prevents normal healing and sensation, often leading to persistent sores, scarring, or vision loss. For investors, it matters because treatments or devices that restore nerve function or promote healing can command regulatory attention, premium pricing, and meaningful demand in a niche but high-need patient population — similar to how a repair kit matters when the wiring in a house keeps shorting out.

vasoactive intestinal peptide medical

"profuse watery diarrhea associated with Vasoactive Intestinal Peptide secreting tumors"

Vasoactive intestinal peptide (VIP) is a small natural signaling molecule that helps relax blood vessels, calm inflammation, and control secretion and cell growth—think of it as a traffic director for blood flow and certain immune and digestive functions. Investors monitor VIP because drugs that mimic, block, or modify its effects can become treatments for conditions like pulmonary or inflammatory diseases and cancer, so changes in VIP-related research, trials, or approvals can affect a company’s value.

AI-generated analysis. Not financial advice.

• Receives U.S. Food and Drug Administration (FDA) Approval for Generic Version of Sandostatin^® LAR Depot (Octreotide Acetate for Injectable Suspension)
• U.S. FDA Accepts New Drug Application for Low Dose Estrogen Weekly Patch for Contraception
• U.S. FDA Clears Investigational New Drug Application for MR-146 in Neurotrophic Keratopathy
• Japan Pharmaceuticals and Medical Devices Agency Accepts Japanese New Drug Application Filing for Pitolisant in Obstructive Sleep Apnea Syndrome

PITTSBURGH, Dec. 18, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced four recent regulatory milestones spanning across all stages of its global pipeline:

• Octreotide Acetate for Injectable Suspension: The U.S. Food and Drug Administration (FDA) has approved the Company's octreotide acetate for injectable suspension, a generic version of Sandostatin^® LAR Depot. The therapy is indicated for treatment in patients who have responded to and tolerated Sandostatin Injection subcutaneous injection for acromegaly, severe diarrhea/flushing episodes associated with metastatic carcinoid tumors, and profuse watery diarrhea associated with Vasoactive Intestinal Peptide secreting tumors.
• Low Dose Estrogen Weekly Patch: The U.S. FDA has accepted for review the New Drug Application (NDA) for the Company's investigational low dose estrogen weekly patch (150 mcg norelgestromin and 17.5 mcg ethinyl estradiol) for contraception. The NDA is accepted under the FDA's 505(b)(2) regulatory pathway, and the FDA has assigned a target action date (PDUFA) of July 30, 2026.
• MR-146: The U.S. FDA has cleared the Company's Investigational New Drug (IND) application for MR-146, an Enriched Tear Film^TM (ETF) Adeno-Associated Virus (AAV) gene therapy candidate targeted to treat people with neurotrophic keratopathy (NK). The Company plans to initiate a Phase 1 / 2 clinical trial, CORVITA, for MR-146 in patients with NK in the first half of 2026.
• Pitolisant: The Japan Pharmaceuticals and Medical Devices Agency (PMDA) has accepted the Company's Japanese New Drug Application (J-NDA) for pitolisant in obstructive sleep apnea syndrome (OSAS). The Company remains on track to submit a J-NDA for narcolepsy by the end of the year.

"We are proud of these recent regulatory achievements, which culminate a year of significant R&D advancement in 2025," said Viatris Chief R&D Officer Philippe Martin. "These important milestones not only demonstrate the strength of our scientific and regulatory capabilities, but also our dedication to addressing areas of significant unmet medical need for patients. We look forward to continuing to work closely with health authorities around the world as we progress our pipeline in 2026 and beyond." 

About Octreotide Acetate for Injectable Suspension
Octreotide acetate for injectable suspension is a long-acting medication used to help manage the symptoms of certain rare conditions, including acromegaly (a disorder in adults that causes abnormal growth of bones, organs and tissues) and complications associated with specific cancerous tumors. It is the Company's first approved injectable using microsphere technology.

This approval marks the Company's fourth injectable FDA approval in 2025 – joining iron sucrose, paclitaxel and liposomal amphotericin B – underscoring the Company's ability to successfully navigate complex regulatory pathways and strategy to expand its generics portfolio with technically complex, high-value products.

About Low Dose Estrogen Weekly Patch for Contraception
The investigational treatment is a once-weekly transdermal contraceptive patch being developed for women of childbearing potential with a BMI below 30 kg/m² who are appropriate candidates for combined hormonal contraception and who prefer a non-invasive, reversible option with a lower estrogen dose. The patch delivers approximately 150 mcg of norelgestromin and 17.5 mcg of ethinyl estradiol per day and is applied once weekly for three weeks, followed by a one-week patch-free period.

The planned 505(b)(2) NDA is supported by results from the Phase 3 Luminous Study, which demonstrated a favorable efficacy and safety profile and strong patch adhesion performance.

The patch represents the potential to meet an important unmet medical need for women seeking alternatives to regular estrogen dose and long-acting contraception treatments. This investigational treatment option builds upon the Company's established capability in transdermal drug delivery and represents a lifecycle advancement of the contraceptive patch Xulane^® (norelgestromin and ethinyl estradiol transdermal system) 150/35 mcg per day.

About MR-146 for Neurotrophic Keratopathy
NK is a rare but potentially sight-threatening corneal disease, which impacts approximately 73,000 people in the United States. It is a degenerative disease that causes progressive damage to the cornea. The most common causes of the disease are viral infections (herpes simplex, varicella zoster [shingles]), diabetes, multiple sclerosis, chemical burns, dry eye disease and corneal surgeries.

MR-146 utilizes an ETF^TM AAV gene therapy platform, a first-of-its-kind approach designed to be delivered directly to the lacrimal gland via a single injection, using non-replicating DNA delivery transporters for the production and delivery of human Nerve Growth Factor (hNGF) protein to the cornea via tears. NK is the first indication of many that could be treated with this platform.

About Pitolisant
Pitolisant is a selective histamine H3 receptor antagonist/inverse agonist that modulates the brain's sleep–wake pathways.

The J-NDA application is supported by positive Phase 3 data in Japanese patients. The Phase 3 trial evaluated the effect of pitolisant in Japanese patients with OSAS who were experiencing residual Excessive Daytime Sleepiness (EDS) despite treatment with CPAP therapy. At the end of the 12-week treatment period, patients receiving pitolisant scored lower on the Epworth Sleepiness Scale used to measure EDS compared to those in the placebo group, and this difference was statistically significant (p=0.007). Additionally, safety and tolerability were consistent with results from global clinical studies.

About Viatris
Viatris Inc. (Nasdaq: VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on LinkedIn, Instagram, YouTube and X.

Forward-Looking Statements
This press release includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include statements that Viatris provides pipeline update on four regulatory milestones; receives FDA approval for generic version of Sandostatin® LAR Depot (octreotide acetate for injectable suspension); FDA accepts NDA for low dose estrogen weekly patch for contraception; FDA clears IND application for mr-146 in neurotrophic keratopathy; Japan Pharmaceuticals and Medical Devices Agency accepts J-NDA new drug application filing for pitolisant in obstructive sleep apnea syndrome; the NDA is accepted under the FDA's 505(b)(2) regulatory pathway, and the FDA has assigned a target action date (PDUFA) of July 30, 2026; Viatris plans to initiate a Phase 1 / 2 clinical trial, CORVITA, for MR-146 in patients with NK in the first half of 2026; the Company remains on track to submit a J-NDA for narcolepsy by the end of the year; we are proud of these recent regulatory achievements, which culminate a year of significant R&D advancement in 2025; these important milestones not only demonstrate the strength of our scientific and regulatory capabilities, but also our dedication to addressing areas of significant unmet medical need for patients; we look forward to continuing to work closely with health authorities around the world as we progress our pipeline in 2026 and beyond; octreotide acetate for injectable suspension is the Company's first approved injectable using microsphere technology; this approval marks the Company's fourth injectable FDA approval in 2025 – joining iron sucrose, paclitaxel and liposomal amphotericin B – underscoring the Company's ability to successfully navigate complex regulatory pathways and strategy to expand the generics portfolio with technically complex, high-value products; the planned 505(b)(2) NDA is supported by results from the Phase 3 Luminous Study, which demonstrated a favorable efficacy and safety profile and strong patch adhesion performance; the patch represents the potential to meet an important unmet need for women seeking alternatives to regular estrogen dose and long-acting contraception treatments; this investigational treatment option builds upon the Company's established capability in transdermal drug delivery and represents a lifecycle advancement of the contraceptive patch Xulane^® (norelgestromin and ethinyl estradiol transdermal system) 150/35 mcg per day; NK is the first indication of many that could be treated with this candidate; the J-NDA application is supported by positive Phase 3 data in Japanese patients; at the end of the 12-week treatment period, patients receiving pitolisant scored lower on the Epworth Sleepiness Scale used to measure EDS compared to those in the placebo group and this difference was statistically significant (p=0.007); additionally, safety and tolerability were consistent with results from global clinical studies. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the uncertainties inherent in research and development, including the outcomes of clinical trials; the ability to meet anticipated clinical endpoints; the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from clinical studies; actions and decisions of healthcare and pharmaceutical regulators; our ability to comply with applicable laws and regulations; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; any regulatory, legal or other impediments to Viatris' ability to bring new products to market; products in development and/or that receive regulatory approval may not achieve expected levels of market acceptance, efficacy or safety; longer review, response and approval times as a result of evolving regulatory priorities and reductions in personnel at health agencies; Viatris' or its partners' ability to develop, manufacture, and commercialize products; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings on Viatris; Viatris' failure to achieve expected or targeted future financial and operating performance and results; goodwill or impairment charges or other losses; any changes in or difficulties with the Company's manufacturing facilities; risks associated with international operations; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties regarding future demand, pricing and reimbursement for the Company's products; uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions, potential adverse impacts from future tariffs and trade restrictions, inflation rates and global exchange rates; and the other risks described in Viatris' filings with the Securities and Exchange Commission ("SEC"). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this press release other than as required by law.

 

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SOURCE Viatris Inc.

FAQ

What did Viatris announce about FDA approval for octreotide acetate (VTRS) on Dec 18, 2025?

Viatris announced FDA approval of its generic octreotide acetate injectable suspension, a generic of Sandostatin LAR Depot.

When is the PDUFA date for Viatris's low dose estrogen weekly patch (VTRS)?

The FDA assigned a target action (PDUFA) date of July 30, 2026 for the NDA under 505(b)(2).

What is the clinical plan after FDA cleared the IND for MR-146 (VTRS)?

Viatris plans to initiate the Phase 1/2 CORVITA trial for MR-146 in neurotrophic keratopathy in H1 2026.

Did Japan accept a Viatris J-NDA for pitolisant (VTRS)?

Yes; the Japan PMDA accepted the J-NDA for pitolisant in obstructive sleep apnea syndrome.

How do these regulatory milestones affect Viatris's near-term risk (VTRS)?

They advance multiple programs but leave binary regulatory and clinical outcomes pending that will determine near-term impact.

Will Viatris still submit a J-NDA for narcolepsy in 2025 (VTRS)?

The company said it remains on track to submit a J-NDA for narcolepsy by year-end.